This week's sponsor is CMIC Group. | | | Today's Rundown FDA questions credibility of Daiichi data ahead of AdComm ElevateBio uncloaks with $150M to build cell and gene therapy biotechs Italian cancer startup Philogen gets off an impressive $70M funding round Pulmonx raises $65M to market its lung valve implant worldwide Teva starred in price-fixing scheme, but 19 other companies 'willingly' joined, attorneys general claim Featured Story | Monday, May 13, 2019 The FDA has questioned the reliability of the phase 3 results Daiichi Sankyo hopes will win it approval for quizartinib in acute myeloid leukemia. Officials raised the concerns in a briefing document to support an upcoming advisory committee meeting. |
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| Top Stories Monday, May 13, 2019 ElevateBio seeks to address a bottleneck faced by cell and gene therapy developers: manufacturing. With $150 million in series A funding, the holding company will provide centralized R&D and manufacturing teams to its portfolio companies. Monday, May 13, 2019 Quiet antibody biotech Philogen, which has had a difficult and long path, got off a healthy €62 million ($70 million) funding round and brought on new board members as it looks to push on with late-stage development of its oncology assets after decades of development. Monday, May 13, 2019 Pulmonx, maker of an airway valve implant for patients with serious lung disease, has secured $65 million in new equity financing for its global commercialization efforts through an oversubscribed round led by the Hong Kong-based Ally Bridge Group. Monday, May 13, 2019 In what could be "the largest cartel case in the history of the United States," 44 states sued 20 generics makers Friday for price fixing and personally named 15 of those companies' executives. And at the center of the scheme, the lawsuit claims, was Teva. This week's sponsor is ExL Events. | | | Resources Sponsored by: Catalent Download the executive summary to learn key considerations for a successful technology transfer for manufacturing drug products, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Patheon, part of Thermo Fisher Scientific Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs. Sponsored by: Patheon, part of Thermo Fisher Scientific Designed with speed & flexibility,Quick to Clinic™ for Oral Solid Dose helps deliver products to Phase I Clinic in as little as 14 weeks. Sponsored by: AlphaSense What is agile competitive intelligence, and how can help healthcare researchers stay ahead of the curve? Sponsored by: JPEO-CBRND – Medical Countermeasure Systems MCS is currently seeking broad-based industry/academia collaboration on research and prototype work in technical areas related to developing medical countermeasures for the Joint Warfighter. Sponsored by: Outer Edge Technology Learn how the cloud can support the performance and security requirements for validated, mission-critical applications historically designed and implemented exclusively via on-premises deployment. Presented by: Total Brain Total Brain Announces Personalized Test for Treatment Prediction in Depression with 80% Accuracy. Sponsored by: Veradigm Prescription price transparency technology is here – but is it making a difference? Find out HERE. Sponsored by: Biotech Primer The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry. Drug Development Immersion May 16-17, 2019 | Boston, MA 2019 BIO International Convention June 3-6, 2019 | Philadelphia, PA FierceBiotech Executive Breakfast at BIO 2019 – Getting Real: The Changing Tide on Real-World Evidence in Drug Development June 5, 2019 | Philadelphia, PA World Pharma Week June 17-20, 2019 | Seaport World Trade Center | Boston, MA Medical Sensors Design Conference June 25, 2019 | McEnery Convention Center | San Jose, CA Sensors Expo & Conference June 25-27, 2019 | McEnery Convention Center | San Jose, CA Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! |